MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACROMIONIZER,5.5,EP-1,DSPL BL(6); SAW, POWERED, AND ACCESSORIES

Model Number	7205327
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device put metal shavings into the joint while in use.All the pieces were removed.A backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
One used 5.5 mm acromionizer burr was returned for evaluation.Visual assessment of the burr showed a contact point on a section of the inner sheath which coincides with the bronze bushing.Dimensional assessment found the device met print specifications.The burr was shed tested and the reported shedding was confirmed.A re-design the inner burr has been initiated, as part of the re-design the bronze bushing will be replaced by a secondary shrink tubing.This improvement will eliminate this mode of shedding.

• Brand Name: ACROMIONIZER,5.5,EP-1,DSPL BL(6)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7797009
• Report Number: 1219602-2018-01095
• Device Sequence Number: 13930359
• Product Code: HAB
• UDI-Device Identifier: 03596010251558
• UDI-Public: (01)03596010251558(17)220713(10)50674360
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/13/2022
• Device Model Number: 7205327
• Device Catalogue Number: 7205327
• Device Lot Number: 50674360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 07/25/2018; 08/27/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 08/20/2018; 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1